Explainer: Patent term extension with Hatch Waxman
Plus! Stylish medical gloves, Offshore LNG, and Orrick's new litigator
Over the years, there have been academic discussions of the idea of different patent terms for different fields. Typically these conversations focus around the market conditions of different industries. But there are also regulatory reasons. Inventors often create products in regulated spaces and receive their patents years before they receive regulatory approval to market the products they produce even though the regulatory approval cuts into the time they are supposed to be able to benefit from the exclusivity period. As a result, they do not fully enjoy the fruits of their patent protection. What the government giveth with one hand, it taketh away with another.
Nowhere is this problem more pronounced than the pharmaceutical industry, which is not only one of the most patent-heavy industries on the planet but also perhaps the only industry with universal prior restraint. Thankfully, in recognition of this issue, Congress has created a mechanism for patent term extension, or PTE, called the Hatch-Waxman Act. Under the right circumstances, you can extend the life of your patent by up to fourteen years! If you’re working on drugs, this is how to get more out of your IP that you’ve worked so hard for.
How patent term extension works
Hatch-Waxman is a unique law from 1984 that was intended to incentivize the creation of generic drugs while also incentivizing innovation. Although PTE comes from a law that was focused on drugs, you can extend the life of your patent if it is for an innovation in human or animal drugs, food or color additives, medical devices, and veterinary biological products.1 The PTE will make up for the lost time waiting for premarket approval from a regulatory agency like the FDA. That said, there are rules you have to follow, and it isn’t a one-to-one restoration. Also, a quick note: patent term extension is not the same thing as patent term adjustment.
Under Hatch Waxman, you get back the total period of your regulatory review period that took place during your patent term. However, the government takes back half of the days during its “testing period,” which is essentially the time between the IND and the NDA/BLA. One last thing is that you have to be “diligent,” meaning that if you are deemed to be the cause of the delay rather than the FDA, you are on the hook for the days caused by your delay and do not get any extension for those days.2 You can only apply for PTE once per product, and you must have been successfully approved to go to market. The maximum is once per product and fourteen years total. And keep in mind that this isn’t a general extension of the patent; it only applies to the products relevant to the extension under Merck v. Kessler (1998).
PTE is not easy to get. On average, over the past five years, there have only been 128 extension applications per year, with the typical extension lasting 2-3 years. If your application is rejected, you can request a reconsideration within two months; if you fail to respond, your application is considered abandoned. If your application is accepted, but you think it should have been longer, you have one month to request a reconsideration. But if you get PTE, congratulations! You will have potentially years longer to market your product.3 Considering that some drugs produce over $10 million in revenue per day, that is worth a lot.
There is another part of Hatch-Waxman that makes it easier to file for generics manufacturers. How does it work? Has it been a success? What does it have to do with orange books? That will come in another blog post. Make sure to subscribe to learn more.
Gripping Gazette entries
US 11,759,090 B2: An analysis algorithm from Auris Health for examining airways with artificial intelligence, mainly for surgical robotics systems
US 11,760,359 B2: An algorithm for detecting abnormalities while driving, and then having the car automatically respond
US 11,760,446 B2: Offshore liquid natural gas facilities and claims relating to their process facilities
TrackTime LLC v. Amazon.com Services LLC, U.S. District Court for the District of Delaware, No. 1:18-cv-01518: Amazon wins an infringement case for its Audible service in defense against a multimedia patent
In the Matter of Certain Audio Players and Components Thereof (II), U.S. International Trade Commission, No. 337-TA-1330: Sonos prevails against Google in the initial determination of the ITC 337 case in their ongoing patent saga
10x Genomics Inc v. Parse Biosciences Inc, U.S. District Court for the District of Delaware, No. 1:22-cv-01117: Several key gene patents are upheld on 101 abstract idea grounds for 10x Genomics
US 6618861 B2: Medical gloves with a watch hole, for keeping a pulse during surgery or just for doctors with style
US 6618864 B2: A toilet with automatic flushing and seat-raising, truly the demarcation line for civilization
US 6618941 B2: A method of forming freestanding metal dendrites for at-the-time increasingly dense substrates, perhaps semiconductors
Notable news items
Raghav Krishnapriyan joined Orrick’s litigation practice (Bloomberg Law)
BYD has 16x more patents than Tesla; not surprising given Tesla’s stance on patents (Nikkei)
An interview on prizes instead of patents for drugs in light of Bernie Sanders’ (I-VT) recent proposal; this idea comes up now and again, but prizes have many known issues in incentivizing innovation (Stat News)
As a technical matter, the claim can be a utility claim for the product itself or a method claim for using or manufacturing the product.
Diligence is only even considered in the case of a diligence petition. But be warned, anyone can file a petition within 180 days.
USPTO will publish a notice of your term extension, but they won’t issue a new patent.